Department of Radiology, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, 59 Daesagwan-gil, Hannam-dong, Yongsan-gu, Seoul, 04401, South Korea.
Department of Radiology, Konkuk University Hospital, Konkuk University College of Medicine, Seoul, Korea.
Cardiovasc Intervent Radiol. 2024 Jan;47(1):36-44. doi: 10.1007/s00270-023-03536-5. Epub 2023 Nov 27.
To evaluate the efficacy and safety of drug-coated balloon angioplasty compared to conventional balloon angioplasty in the treatment of dysfunctional arteriovenous grafts.
This prospective, multicenter, randomized clinical trial enrolled 190 patients with venous anastomotic stenosis in arteriovenous grafts at five participating hospitals. During pre-dilation, 4 patients dropped out due to ruptures requiring further treatment (n = 2) and residual stenosis of > 30% (n = 2). On successful pre-dilation with a 7 mm conventional balloon, patients were randomized to undergo either a 7 mm drug-coated balloon (n = 94) or conventional balloon angioplasty (n = 92). The primary out-come measure was target lesion primary patency at 3 and 6 months. The secondary out-come measures included target lesion primary patency at 12 months and access circuit primary patency at 6 and 12 months, clinical and technical success rates, and 12-month mortality differences between the groups.
The target lesion primary patency and access circuit patency rates at 3 and 6 months were significantly higher in drug-coated balloon angioplasty group as compared to conventional balloon angioplasty group. The technical and clinical success rates were 100% for both the groups. As a procedure-related complication, anastomotic site rupture occurred during pre-dilation in 4 cases. The number of deaths during the 12-month follow-up was one for each group. The number of early thrombotic events (at < 3 months) was significantly higher in the drug-coated balloon group (p = 0.002).
Drug-coated balloon angioplasty was more effective and safer for the treatment of dysfunctional arteriovenous grafts compared to conventional balloon angioplasty.
评估药物涂层球囊血管成形术与传统球囊血管成形术治疗功能失调动静脉移植物的疗效和安全性。
这项前瞻性、多中心、随机临床试验纳入了 5 家参与医院的 190 例动静脉移植物静脉吻合口狭窄患者。在预扩张过程中，4 例患者因破裂（需进一步治疗 2 例，残余狭窄>30% 2 例）而退出。在成功预扩张后使用 7mm 常规球囊，患者被随机分为药物涂层球囊（n=94）或常规球囊血管成形术（n=92）组。主要终点是 3 个月和 6 个月时的靶病变一期通畅率。次要终点包括 12 个月时的靶病变一期通畅率和 6 个月和 12 个月时的通路循环一期通畅率、临床和技术成功率以及两组之间 12 个月死亡率的差异。
与传统球囊血管成形术相比，药物涂层球囊血管成形术组在 3 个月和 6 个月时的靶病变一期通畅率和通路循环通畅率显著更高。两组的技术成功率和临床成功率均为 100%。作为一种与手术相关的并发症，预扩张过程中 4 例发生吻合口破裂。在 12 个月的随访期间，每组各有 1 例死亡。药物涂层球囊组（p=0.002）早期血栓形成事件（<3 个月）的数量明显更高。
与传统球囊血管成形术相比，药物涂层球囊血管成形术治疗功能失调动静脉移植物更有效、更安全。
